MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO MTS PWLD EXCLUDES FLOOR PLATE; STRETCHER, WHEELED

Catalog Number	639005550003
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.1 device is pending evaluation.There was no remedial action taken.This device is not labeled for single use.
Event or Problem Description
This report summarizes 1 malfunction event, where it was reported the device experienced fastener no longer facilitates proper cot operations during loading/unloading.There was 1 event with patient involvement; no adverse consequences were reported.
Event or Problem Description
This report summarizes 0 malfunction event, where it was reported the device experienced fastener no longer facilitates proper cot operations during loading/unloadin.There was no patient involvement.
Additional Manufacturer Narrative
It was originally reported that the fastener no longer facilitates proper cot operations during loading/unloading.After evaluation, it was found that the issue was not with this device.Because of this, the number of reported events has been changed from 1 to 0.

• Brand Name: MTS PWLD EXCLUDES FLOOR PLATE
• Common Device Name: STRETCHER, WHEELED
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer (Section G): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer Contact: melissa simon ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 19162977
• Report Number: 0001831750-2024-00630
• Device Sequence Number: 7303934
• Product Code: FPO
• UDI-Device Identifier: 07613327504453
• UDI-Public: 07613327504453
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K113598
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 639005550003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2024
• Supplement Date Received by Manufacturer: 04/01/2024
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown